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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K202216
Device Name EPIQ Series Diagnostic Ultrasound Systems
Applicant
Philips Ultrasound, Inc.
22100 Bothell Everett Highway
Bothell,  WA  98021 -8431
Applicant Contact Colin S. Jacob
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OBJ  
Date Received08/06/2020
Decision Date 09/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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